Clinical trial · Observational
Optimising Mammography Screening Accuracy With Blood-based Biomarkers
OPTIMA: Optimising Mammography Assesment Via Blood-based Biomarkers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The project aims to investigate whether breast cancer screening can be improved using blood tests, thereby reducing the number of unnecessary clinical mammographies. The Danish breast cancer screening program was implemented in 2007, and currently, all women aged 50-69 are invited every two years to participate. Those who have a suspecious screening mammography are referred to a clinical mammography where further assesment with more mammographies, ultra-sound and possibly biopsies are conducted. Around 75% of the women that are referred to further assesment can be classified as unnecessary, as no breastcancer is found. This results in avoidable and unpleasant procedures for individuals and strains healthcare resources. The project seeks to reduce the number of these unnecessary clinical mammographies by investigating whether blood biomarkers can identify women at very low risk of breast cancer after a positive mammography screening. By utilizing blood tests, screening could become more personalized, precise, and resource-efficient for the healthcare system.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Mammography screening positive women
- description
- All citizens referred to a clinical mammography at Vejle Hospital or Odense University Hospital in the breast cancer screening program are offered to participate in the study. If the participant agrees, they will have blood drawn and sign a declaration of consent. Statistically, approximately 25 % will be diagnosed with breastcancer
Primary outcomes (1)
- measure
- Correlation between blood samples and clinical mammography result
- timeFrame
- 6 weeks from clinical mammography date
- description
- The aim is to investigate the womens chance of being healthy despite a positive tmammography screening. The chance of being healthy is estimated from the combined blood sample results and will be compared to the results of the clinical mammography.
Secondary outcomes (1)
- measure
- Correlation between blood samples and interval breast cancer
- timeFrame
- From 6 weeks after the clinical mammography to next mammographyscreening, up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Participation in the Danish breast cancer screening program Exclusion Criteria: * No clinical mammography conducted
References
Publications (0)
Data not yet available